| アブストラクト | PURPOSE: Abraxane (nanoparticle albumin-bound paclitaxel) is a chemotherapeutic employed commonly for the management of various cancers including breast cancer, non-small cell lung cancer, and pancreatic adenocarcinoma. Although it has clinically beneficial properties, Abraxane is accompanied by multiple adverse events (AEs) that require close observation. This study aims to evaluate the AE profile of Abraxane using recently available data from January 2004 through December 2023 in the FDA Adverse Event Reporting System (FAERS). PATIENTS AND METHODS: The data for Abraxane-related AEs were obtained from the FAERS database. The dataset consisted of patient demographic characteristics as well as information on the types and outcomes of AEs reported. Reporting odds ratios (ROR) as well as proportional reporting ratio (PRR), considering the used definition of anti-cancer agent and AEs, were calculated to investigate any association with Abraxane. RESULTS: A total of 10,310 reports associated with Abraxane AEs were identified. Blood and lymphatic system disorders were the most frequent (ROR 6.44), followed by hepatobiliary (ROR 3.16), infections (ROR 1.45), and gastrointestinal disorders (ROR 1.42). Serious outcomes included hospitalization in 36.35% and death in 29.76% of cases. The top adverse reactions matched known profiles, including peripheral sensory neuropathy (ROR: 49.48). The analysis also found new adverse reactions, such as scleroderma-like reactions (ROR: 95.4) and vascular pseudoaneurysm ruptures (ROR: 87.71). CONCLUSION: Our results re-emphasize the importance of a robust Post Marketing Surveillance system and suggest this FAERS database based analysis provides an updated, independent information on Abraxane related AEs to enrich its safety profile. A process of continuous vigilance and additional investigations on specific areas that may have some undesired events are imperative to increase our knowledge on how Abraxane should be handled in terms of its safety. |
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| ジャーナル名 | International journal of nanomedicine |
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| Pubmed追加日 | 2024/11/19 |
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| 投稿者 | Zhao, Yue-Chen; Li, Xin; Wang, Chao-Qun; Jiao, Yan; Shen, Yan-Nan; Wang, Tie-Jun; Zhang, Chao-He |
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| 組織名 | Department of Radiation Oncology, The Second Hospital of Jilin University,;Changchun, Jilin, People's Republic of China.;NHC Key Laboratory of Radiobiology, School of Public Health, Jilin University,;Department of Radiology, The Second Hospital of Jilin University, Changchun,;Jilin, People's Republic of China.;Department of Gynaecology, Aviation General Hospital, Beijing, People's Republic;of China.;Department of Hepatobiliary and Pancreatic Surgery, General Surgery Center, First;Hospital of Jilin University, Changchun, People's Republic of China.;Department of Hematology and Oncology, The Second Hospital of Jilin University, |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39558918/ |
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